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Modified-release calcifediol effectively controls secondary hyperparathyroidism associated with vitamin D insufficiency in chronic kidney disease.
- Source :
-
American journal of nephrology [Am J Nephrol] 2014; Vol. 40 (6), pp. 535-45. Date of Electronic Publication: 2015 Jan 07. - Publication Year :
- 2014
-
Abstract
- Background/aims: Vitamin D insufficiency drives secondary hyperparathyroidism (SHPT) and is associated with increased cardiovascular mortality in patients with chronic kidney disease (CKD). SHPT is poorly addressed by current vitamin D repletion options. The present study evaluated a novel investigational vitamin D repletion therapy: a modified-release (MR) formulation of calcifediol designed to raise serum 25-hydroxyvitamin D in a gradual manner to minimize the induction of CYP24 and, thereby, improve the SHPT control.<br />Methods: This randomized, double-blind, placebo-controlled trial evaluated MR calcifediol in CKD subjects (n = 78) with plasma intact parathyroid hormone (iPTH) >70 pg/ml and serum total 25-hydroxyvitamin D <30 ng/ml. Subjects received daily treatment for six weeks with oral MR calcifediol (30, 60 or 90 µg) or a placebo.<br />Results: More than 90% of subjects treated with MR calcifediol achieved serum 25-hydroxyvitamin D levels ≥30 ng/ml versus 3% of subjects treated with placebo (p < 0.0001). Mean plasma iPTH decreased from baseline (140.3 pg/ml) by 20.9 ± 6.2% (SE), 32.8 ± 5.7 and 39.3 ± 4.3% in the 30, 60 and 90 µg dose groups, respectively, and increased 17.2 ± 7.8% in the pooled placebo group (p < 0.005). No clinically significant safety concerns arose during MR calcifediol treatment.<br />Conclusion: Oral MR calcifediol appears safe and highly effective in treating SHPT associated with vitamin D insufficiency in CKD.
- Subjects :
- Adult
Aged
Calcifediol blood
Delayed-Action Preparations
Double-Blind Method
Female
Humans
Hyperparathyroidism, Secondary blood
Hyperparathyroidism, Secondary etiology
Male
Middle Aged
Parathyroid Hormone blood
Renal Insufficiency, Chronic blood
Vitamin D blood
Vitamin D Deficiency blood
Vitamin D Deficiency etiology
Vitamins blood
Calcifediol administration & dosage
Hyperparathyroidism, Secondary drug therapy
Renal Insufficiency, Chronic complications
Vitamin D analogs & derivatives
Vitamin D Deficiency drug therapy
Vitamins administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1421-9670
- Volume :
- 40
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- American journal of nephrology
- Publication Type :
- Academic Journal
- Accession number :
- 25572630
- Full Text :
- https://doi.org/10.1159/000369939